Drug and pharmaceutical recalls
17731 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2016-10-12FDA-DrugShireClass IIIVyvanse (lisdexamfetamine dimesylate) Capsules 30 mg, 100 count bottle, Rx Only, Manufactured for: Shire US, Inc., Lexington, MA 02421, NDC 59417-103-10
Presence of Foreign Tablets/Capsules
- 2016-10-12FDA-DrugTeva North AmericaClass IIIClaravis (isotretinoin capsules USP), 10mg, packaged in carton containing 3 Blister Packs of 10 Capsules Each (30 Capsules total); Rx only, TEVA PHARMACEUTICALS USA, Sellersville, PA 18960. NDC 00555-1054-86
Failed Impurities/Degradation Specifications.
- 2016-10-12FDA-DrugThe Apothecary Shoppe LLCClass IITri-Mix 18/1/10 (Papaverine 18mg, Phentolamine 1 mg, Prostaglandin 10 mcg/mL) packaged in 2.5 mL sterile vials, IM, Rx, The Apothecary Shoppe, Jenks, OK
Lack of Assurance of Sterility; medication was sterilized with a recalled filter
- 2016-10-12FDA-DrugThe Apothecary Shoppe LLCClass IIPhenotolamine 0.4mg/Prostaglandin 20mcg/mL packaged in 2.5 mL sterile vials, IM, Rx, The Apothecary Shoppe, Jenks, OK
Lack of Assurance of Sterility; medication was sterilized with a recalled filter
- 2016-10-12FDA-DrugThe Apothecary Shoppe LLCClass IIStop using The Apothecary Shoppe methylcobalamin injection
Lack of Assurance of Sterility; medication was sterilized with a recalled filter
- 2016-10-12FDA-DrugBiocompatibles U.K., Ltd.Class IIIDo not use Varithena administration pack
Defective Delivery System: Incorrect type of syringe found in commercially distributed administration pack
- 2016-10-05FDA-DrugMckesson Packaging ServicesClass IIILansoprazole Delayed-Release Capsules, USP, 30 mg, packaged in 100-count cartons of 10 x 10 unit dose blister cards, Rx only, Manufactured by: Dr. Reddy's Laboratories, Inc., 200 Somerset Corporate Blvd Floor 7, Bridgewater, NJ 08807, NDC 63739-0555-10
Labeling: Label mix-up. The inner packaging was properly labeled Omeprazole DR 40mg Capsules, but the outer secondary packaging was mislabeled Lansoprazole Delayed-Release 30mg Capsules.
- 2016-10-05FDA-DrugPharmacy Plus, Inc. dba Vital Care CompounderClass IIDMSO 50% with Lidocaine 0.5%, 50ml SDV, Sterile, Rx, Vital Care Compounder, Hattiesburg, MS
Lack of Assurance of Sterility
- 2016-10-05FDA-DrugPharmacy Plus, Inc. dba Vital Care CompounderClass IIHyaluronidase, 150 u/ml, 10 ml SDV, Vital Care Compounder, Hattiesburg, MS 39402
Lack of Assurance of Sterility
- 2016-10-05FDA-DrugPharmacy Plus, Inc. dba Vital Care CompounderClass IIC-PAP/PHEN/PROST/Atrop 150/7.5 (Papaverine 150mg/Phentolamine 7.5mg/Prostaglandin 75mcg/Atropine 1mg injection), 10 ml vial containing 5.9ml solution, Rx, Vital Care Compounder, Hattiesburg, MS
Lack of Assurance of Sterility
- 2016-10-05FDA-DrugPharmacy Plus, Inc. dba Vital Care CompounderClass IIOlopatadine 0.8% Ophthalmic Solution, 3ml bottle, Rx, Vital Care Compounder, Hattiesburg, MS
Lack of Assurance of Sterility
- 2016-10-05FDA-DrugPharmacy Plus, Inc. dba Vital Care CompounderClass IIC-PAP/PHEN/PROST/ATROP 150/5/5 (Papaverine 150mg/Phentolamine 5mg/Prostaglandin 50mcg/Atropine 0.04mg injection), Rx, 10 ml vials contain 5.8 ml solution, Vital Care COMPOUNDER, Hattiesburg, MS 39402
Lack of Assurance of Sterility
- 2016-10-05FDA-DrugPharmacy Plus, Inc. dba Vital Care CompounderClass IIHydroxyzine HCl, 50mg/ml Inj, 10ml MDV, Rx, Vital Care Compounder, Hattiesburg, MS
Lack of Assurance of Sterility
- 2016-10-05FDA-DrugPharmacy Plus, Inc. dba Vital Care CompounderClass IIPre-Op Pledget Soln + Tetracaine, (Tropicamide (1%) 0.47ml, Phenylephrine (10%) 0.93ml, Ketorolac (0.5%) 0.47l, Ofloxacin (0.3) 0.95, Tetracaine (0.5%), 3ml vial, Rx, Vital Care Compounder, Hattiesburg, MS
Lack of Assurance of Sterility
- 2016-10-05FDA-DrugPharmacy Plus, Inc. dba Vital Care CompounderClass IIPre-Op Pledget Soln, Ophthalmic Drops (Tropicamide (1%) 0.33ml, Phenylephrine (10%) 0.66ml, Ketorolac (0.5%) 0.33ml, Ofloxacin (0.3) 0.67ml, 2ml vial, Rx, Vital Care Compounder, Hattiesburg, MS
Lack of Assurance of Sterility
- 2016-10-05FDA-DrugPharmacy Plus, Inc. dba Vital Care CompounderClass IIAutologous Serum Tears, 2 vials, Rx, Vital Care Compounder, Hattiesburg, MS 39402
Lack of Assurance of Sterility
- 2016-10-05FDA-DrugPharmacy Plus, Inc. dba Vital Care CompounderClass IIMethylcobalamin 5,000mcg/ml, 1mL SDV, Rx, Vital Care Compounder, Hattiesburg, MS 39402
Lack of Assurance of Sterility
- 2016-10-05FDA-DrugPharmacy Plus, Inc. dba Vital Care CompounderClass IIMorphine Sulfate 15mg/ml Injection, 20 ml MDV, Rx, Vital Care Compounder, Hattiesburg, MS
Lack of Assurance of Sterility
- 2016-10-05FDA-DrugPharmacy Plus, Inc. dba Vital Care CompounderClass IIMoxifloxacin HCl 1 mg/ml (0.1mg/0.1ml) and BSS solution, 2ml Single use vial, Rx, Vital Care Compounder, Hattiesburg, MS 39402
Lack of Assurance of Sterility
- 2016-10-05FDA-DrugPharmacy Plus, Inc. dba Vital Care CompounderClass IIBrilliant Blue G (BBG) 0.025%, 0.5 ml SDV, Rx, Vital Care Compounder, Hattiesburg, MS 39402
Lack of Assurance of Sterility
- 2016-10-05FDA-DrugPharmacy Plus, Inc. dba Vital Care CompounderClass IITrypan Blue 0.3%, 0.5ml vials, Rx, Vital Care Compounder, Hattiesburg, MS 39402
Lack of Assurance of Sterility
- 2016-10-05FDA-DrugPharmacy Plus, Inc. dba Vital Care CompounderClass IIPapaverine 150 mg/Phentolamine 5 mg and Prostaglandin 50 mcg, packaged as 5.5 mL in a 10 mL MDV, Rx only, Vital Care Compounder, Hattiesburg, MS 39402
Lack of Assurance of Sterility
- 2016-10-05FDA-DrugPharmacy Plus, Inc. dba Vital Care CompounderClass IIPapaverine 150 mg / Phentolamine 5 mg vials, packaged 5.5 mL in a sterile, clear 10 mL MDV, Rx only, Sterile Injection, Vital Care Compounder, Hattiesburg, MS 39402
Lack of Assurance of Sterility
- 2016-10-05FDA-DrugPharmacy Plus, Inc. dba Vital Care CompounderClass IIMOXI/DEX/KETOROLAC 0.5%/0.1%/0.4%, #15, Vital Care Compounder, Hattiesburg, MS 39402
Lack of Assurance of Sterility
- 2016-10-05FDA-DrugPharmacy Plus, Inc. dba Vital Care CompounderClass IIMoxifloxacin 0.5% + Dexamethazone 0.1%, 15ml vial Contains: Moxifloxacin 5mg/ml, Dexamethasone Sodium Phosphate 1mg/ml, Rx only, For ophthalmic use only, Vital Care Compounder, Hattiesburg, MS
Lack of Assurance of Sterility
- 2016-10-05FDA-DrugPharmacy Plus, Inc. dba Vital Care CompounderClass IIApomorphine HCl 3mg/ml Sterile Injection Solution, 10 mL, MDV, Rx, Vital Care Compounder, Hattiesburg, MS
Lack of Assurance of Sterility
- 2016-10-05FDA-DrugPharmacy Plus, Inc. dba Vital Care CompounderClass IIBuprenorphine, 0.6 mg/ml Injection, 20ml MDV Sterile, Rx, Vital Care Compounder, Hattiesburg, MS
Lack of Assurance of Sterility
- 2016-10-05FDA-DrugPharmacy Plus, Inc. dba Vital Care CompounderClass IIChlorpheniramine Maleate 10 mg/ml, 30 ml MDV, Rx, Vital Care Compounder, Hattiesburg, MS 39402
Lack of Assurance of Sterility
- 2016-10-05FDA-DrugPfizer Inc.Class IIIPREMARIN (conjugated estrogen tablets, USP) 1.25 mg, 1000- count bottle, Rx only, Distributed by: Wyeth Pharmaceuticals Inc. A subsidiary of Pfizer Inc. Philadelphia, PA 19101, NDC 0046-1104-91
Labeling: Incorrect or Missing Lot and/or Exp Date: Bottles were incorrectly labeled with an expiry date of 11/17; the correct date is 09/17.
- 2016-10-05FDA-DrugMckesson Packaging ServicesClass IIIXanax (Alprazolam) USP, CIV, 0.5 mg tablets , 10 x 10 blister cards per carton, Rx Only, Manufactured by Sandoz Inc., Princeton, NJ 08805, NDC 63739-669-10
Labeling: Missing Label-Primary packaging label (i.e. blister card) is blank and contains no product information (e.g. product name, strength, lot number, expiry).
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